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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K953592
Device Name REVOLUTION BOND
Applicant
E&D Dental Products, Inc.
71 Veronica Ave.
Suite 3
Somerset,  NJ  08873
Applicant Contact ED SPEHAR
Correspondent
E&D Dental Products, Inc.
71 Veronica Ave.
Suite 3
Somerset,  NJ  08873
Correspondent Contact ED SPEHAR
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/01/1995
Decision Date 09/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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